Using Learning Teams for Reflective Adaptation for Diabetes and Depression (ULTRA-DM/MDD)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00414986
First received: December 21, 2006
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

The study will randomize 54 primary care practices to two intervention and a comparison groups. Both interventions will involve an on-site Improvement Facilitator who will assist the practice in forming an Improvement Team, using rapid-cycle tests of change, and implementing chronic care office systems for type 2 diabetes and depression. One intervention is based on complexity science and the other is a traditional QI intervention.


Condition Intervention
Type 2 Diabetes
Hyperlipidemia
Hypertension
Depression
Behavioral: Standard CQI intervention
Behavioral: Chronic Care Improvement (CCI) Intervention
Behavioral: Self-directed practice comparison

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Using Learning Teams for Reflective Adaptation

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care [ Time Frame: Baseline, 9, and 18 month ] [ Designated as safety issue: No ]
  • HEDIS-like measures of acute phase management of depression [ Time Frame: Baseline, 9, and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient report (by survey) of their primary care experience [ Time Frame: baseline, 9-months, 18-months ] [ Designated as safety issue: No ]

Enrollment: 1565
Study Start Date: September 2005
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Practice in this arm will receive the Chronic Care Improvement intervention
Behavioral: Chronic Care Improvement (CCI) Intervention
An in-practice change facilitator will assist the Improvement Team in enhancing the relationship infrastructure of the practice and in implementing diabetes and depression office systems.
Experimental: 2
Practices in this arm will receive the standard CQI intervention. An in-practice CQI coordinator will assist the practices in implement a chronic disease registry.
Behavioral: Standard CQI intervention
In-practice change facilitator assists the practice in implementing a chronic disease registry
Active Comparator: 3
Practice in this arm will have access to all chronic care tools, but will not have an in-practice change agent.
Behavioral: Self-directed practice comparison
Practices will have access to all tools used in Arm 1 via a project website

Detailed Description:

Evidence-based guidelines for primary care of diabetes have been established and disseminated, yet adoption of guidelines in community-based primary care practice has been disappointing. This effectiveness study proposes a randomized trial involving 54 community-based primary care practices to test two innovative interventions to improve diabetes and depression care. One intervention, derived from theoretically based and efficacious programs tested in other settings, adopts a broad focus and seeks to improve diabetes and depression care by a) increasing the practice's organizational capacity to manage change, and b) implementing and sustaining chronic care office systems that support clinician efforts to improve care for diabetes. The intervention will combine two integrated components. The first component will utilize an Improvement Facilitator that will assess the practice's current use of chronic care office systems and their organizational capacity to manage change, provide feedback to key stakeholders in the practice, and work with the practice over six months to form an Improvement Team that will both address organizational capacity to create and sustain improvement and implement chronic care systems. In the second component of the intervention, the practice will participate in a local Improvement Collaborative that will afford opportunities to learn and share experiences during implementation and maintenance phases of the intervention with five similar practices in their geographic area. The second intervention is based on traditional QI methods and focuses on a chronic disease registry with regular reports to the physicians. It also uses PDSA cycles to assist in implementing change. This intervention will offer tools to improve diabetes and/or asthma care. Both interventions will be evaluated in two ways. First, a randomized trial using rigorous quantitative methods will measure 2 primary and 3 secondary endpoints at 9 and 18 months, including a) the ADA Physician Recognition Program performance measures by both patient-report and review of the medical record, and b) HEDIS measures of acute phase management of depression, c) assessment of the extent to which practices implement and physicians use elements of the chronic care model in their care of diabetes and depression. Change from baseline to 9 months will assess adoption of chronic care improvements, and change from 9 to 18 months will assess sustainability of improvements. Second, a multimethod assessment process will be used to analyze all qualitative and quantitative data separately to understand how and why the intervention led to the observed effects. The practice assessment will strive to understand which components of the interventions were most effective, their relative costs for implementation, and how they might be further improved. Successful components of the intervention will be refined and made available to our collaborators in the project; the Copic Insurance Company and the Colorado Clinical Guidelines Collaborative, for use in their statewide activities to improve diabetes care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Under primary care for type 2 diabetes

Exclusion Criteria:

  • Are not minimally literate in either English or Spanish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414986

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: David West, PhD Department of Family Medicine, University of Colorado Health Sciences Center
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00414986     History of Changes
Other Study ID Numbers: 05-0457, R18DK067083, MH069806
Study First Received: December 21, 2006
Last Updated: November 21, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Hypertension
Behavioral Symptoms
Cardiovascular Diseases
Dyslipidemias
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014